ProfMoische wrote: Here are the references for anyone interested in learning more about the GMP cert. I am posting this for reference. Bold is mine for emphasis:
MRA and collaboration on GMP compliance
The EU and Canada signed a MRA on GMP. This allows EU authorities and their Canadian counterparts to:
1. rely on each other's GMP inspections;
2. waive batch testing of products on entry into their territories;
3. share information on inspections and quality defects.
4. For more information on MRAs and the scope of the EU-Canada MRA, see Mutual recognition agreements.
EMA also participates in initiatives with partner authorities, including Health Canada, on GMP inspections which aim to better distribute inspections capacity, allowing more sites to be monitored and reducing unnecessary duplication. For more information, see International collaboration on GMP inspections.
Mutual recognition agreements (MRAs) on good manufacturing practice (GMP) allow EU authorities to rely on GMP inspections performed by other regulators, the waiving of re-testing of products imported into the EU, and information sharing on inspections and quality defects of products. The EU has MRAs in place with Australia, Canada, Japan, New Zealand, Switzerland and US, and a similar agreement with Israel (ACAA: agreement on conformity assessment and acceptance of industrial products).
In addition to the above, the European Commission together with EMA cooperates with many other regulatory authorities from non-EU countries. Regulatory dialogue with Chinese Taipei takes the form of video conference meetings held every six months and chaired by DG TRADE, in addition to the mid-term review meeting. Regular meetings also take place with the Republic of Korea (in the context of the Free Trade Agreement). In addition, DG TRADE has also engaged in FTA negotiations with Australia, Chile, Indonesia, Japan, Mexico, New Zealand, Philippines, and recently concluded negotiations with Vietnam. Pharmaceuticals are part of the FTAs.
References:
https://ec.europa.eu/health/human-use/good_manufacturing_distribution_practices_en
https://www.ema.europa.eu/documents/other/questions-answers-impact-mutual-recognition-agreement-between-european-union-united-states-1_en.pdf
https://www.ema.europa.eu/en/news/five-additional-countries-benefit-eu-us-mutual-recognition-agreement-inspections
https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra
https://www.pharmacompass.com/radio-compass-blog/fda-and-eu-differ-on-cgmp-standards-at-the-same-facilities-how-will-they-mutually-recognize-inspections